Biogenerics: On Route to Regulatory Approval?

The generic drug market is now firmly established as a major part of the European pharmaceutical sector, with generics forming a significant proportion of off-patent drug sales, especially in Germany, the Netherlands and the UK. Generic drugs composed of biopharmaceuticals – so-called ‘biogenerics’ – are yet to make an impact however despite the incentive of what is, potentially, a highly-lucrative market. Several of the world’s biggest blockbuster drugs are biopharmaceuticals and have or soon will lose their compound patent protection. The main European patent on erythropoietin for example, the drug that netted Kirin-Amgen approximately U$4bn in sales in 2003, expired at the end of last year. Furthermore, by 2010 it is estimated that nearly half of all new marketing approvals will be for drugs of biotechnological origin (source: IMS Global), making this a potential market no company in the biopharma sector can ignore.